Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France
Open-Label Extension Study to Provide Access to ATH434 in Patients With Multiple System Atrophy
調査の概要
詳細な説明
This is a multicenter, open-label extension (OLE) study designed to provide continued access to the investigational product ATH434 for eligible participants with Multiple System Atrophy (MSA) who have successfully completed the prior Phase 2 clinical trial (ATH434-201) in France. Up to 5 participants will be enrolled. No new participants will be recruited or enrolled in this study.
The primary objective is to monitor long-term safety, tolerability, and clinical response. Eligible participants will receive ATH434 at a dose of 75 mg twice daily (BID) to be taken with food.
The study is divided into two operational phases:
Initial Treatment Phase: Participants will receive treatment for a planned duration of 12 months.
Extension Phase: Participants may continue treatment beyond the initial 12 months based on the investigator's clinical judgment of ongoing benefit, safety, and tolerability. Continued eligibility will be re-evaluated and documented every 3 months.
Participants will undergo a combination of in-clinic and remote visits to perform safety monitoring, clinical evaluations, and investigational product accountability.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Alterity Clinical Trials
- 電話番号：+1 888-556-7582
- メール：clinicaltrials@alteritytx.com
研究場所
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Midi-Pyrenees
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Toulouse、Midi-Pyrenees、フランス、31300
- Hôpital Pierre-Paul Riquet
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New Aquitaine
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Bordeaux、New Aquitaine、フランス、33076
- Centre Hospitalier Universitaire De Bordeaux
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Provence-Alpes-Côte d'Azur Region
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Marseille、Provence-Alpes-Côte d'Azur Region、フランス、13005
- Hôpital de la Timone
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Île-de-France Region
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Paris、Île-de-France Region、フランス、75013
- Hôpital Universitaire Pitié Salpêtrière
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Completed Alterity protocol ATH434-201.
- Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator.
Exclusion Criteria:
- Discontinued prior ATH434 treatment (ATH434-201) for any reason.
- Significant medical or psychiatric condition that may decrease the benefit-risk ratio of participation in this program to an unacceptable level, as per the Investigator's opinion.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：ATH434 75mg BID
Participants who completed the prior ATH434-201 Phase 2 trial will receive ATH434 75 mg orally twice daily (BID).
Treatment consists of an initial 12-month treatment phase, followed by an ongoing extension phase based on investigator assessment of continued clinical benefit, safety, and tolerability
|
ATH434 75 mg tablets administered orally twice daily (BID).
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Baseline to completion of study treatment, an average of 1 year.
|
All AEs will be reviewed at every participant contact and documented in the CRF.
All SAEs will be reported within 24 hours of awareness in accordance with local regulatory requirements.
|
Baseline to completion of study treatment, an average of 1 year.
|
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Change From Baseline in Clinical Laboratory Parameters
時間枠：Baseline to completion of study treatment, an average of 1 year.
|
Clinical laboratory parameters include hematology and blood chemistry panels.
|
Baseline to completion of study treatment, an average of 1 year.
|
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Change From Baseline in Vital Signs
時間枠：Baseline to completion of study treatment, an average of 1 year.
|
Vital signs include blood pressure, pulse, temperature, and respiration rate.
|
Baseline to completion of study treatment, an average of 1 year.
|
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Duration of Exposure to ATH434
時間枠：Baseline to completion of study treatment, an average of 1 year.
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Total duration of treatment with investigational product per participant.
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Baseline to completion of study treatment, an average of 1 year.
|
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Cumulative Dose of ATH434
時間枠：Baseline to completion of study treatment, an average of 1 year.
|
Total cumulative dose of investigational product administered per participant.
|
Baseline to completion of study treatment, an average of 1 year.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ATH434-203
- 2025-524317-88-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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